You Can Build Your Own Car Top Shower, But Should You?

1/25/19

By Elan Sudberg

It’s my strong belief that substandard testing practices are the biggest threat to this industry. At worst, something bad goes undetected and does someone harm. At best, they foster poor quality throughout the industry, allowing products with poor efficacy into the supply chain and sabotaging repeat purchases, while handing ammunition on a silver platter to our critics who think supplements should be regulated like drugs. Subpar testing allows this to happen, and from what I have seen all too often that includes DIY labs unless a manufacturer invests in seriously significant resources in equipment, staffing and training for an in-house lab.

At this point I want to share my favorite DIY story. My family enjoys camping, and we also enjoy showers, so when I ran across a shower contraption for the top of our SUV I decided to buy it. My wife, who grew up with a father who could make or repair anything, said ‘why don’t you just make that?’ in a tone that wasn’t actually a question. Like a good spouse, I assessed the situation and to my delight, the vendor had beat me to the punch with a page on their web site titled: DIY – How to make a car top shower. They had an answer for all those spouses that said, ‘why don’t you just make that?’ showing the exact plans to recreate their product. It had a parts list, diagrams, and pictures of the product all along the evolution of DIY. It proceeded to show steps and then compare that to the finished product. In the end it was clear that yes, you can ‘just make that,’ but for a little more money it will be done perfectly. And you won’t still be working on it in the garage after camping season ends. I decided to let the experts handle this.

While it may be an attractive thought to just buy the instrumentation, hire some fresh grads and use that extra space in the back of the warehouse to set up a lab, believe me, it’s not that easy to turn that into compliant quality testing. An instrument sales rep may not to tell you that though. We see a lot of material passed by internal labs that don’t pass muster when we test them. The circumstances and scenarios are pretty common. Imagine this hypothetical but actually pretty realistic situation: Jeff, recently promoted to Lab Everything, is best buds with Sam in procurement; together they are in control of ingredient quality. Both are aware that the CFO’s job is to be money centric, and not necessarily supportive of employees who insist on thorough testing and rejecting subpar material. We all know the ending to this story…

Additionally, proficient testing requires experience and expertise, and very few people are proficient at multiple test methods and types of equipment. It takes years and years of experience. When I conduct training sessions, as I often do for AHPA and other organizations, I meet people who are expected to be proficient with microscopy after one training session. Generally there is some level of panic on their faces when they mention this. They, along with perhaps a small handful of staff with similar levels of training, are required to conduct these tests, along with HPLC and HPTLC, and have results that can withstand regulatory and third party certification scrutiny, which is pretty much outside the realm of possibility. See the potential problems?

What I have found over the two decades I’ve run Alkemist Labs is that setting up and running a good lab is kind of hard. The margins are tight, a good science team is expensive to staff, and instrumentation is costly to buy and properly maintain. So in the true essence of transparency, I am going to describe what is needed to set up your own small botanical identity testing program. In the end I hope you realize that you should continue to be good at what you are good at because the bitterness of poor quality remains long after the sweetness of low price has gone.

There are many things that need to be thought through first in order to develop an in-house identity testing program for raw materials and finished products.

  1. Will an investment need to be made on new instrumentation and resources (instruments, glassware, chemical solvents etc.)?
  2. Will an additional employee be required to run that particular department? How much time will be spent on training? How much on troubleshooting? What happens to your production schedule when your single staff member gets sick or wants PTO? You may have to hire a few.
  3. What will need to be done to validate methods for your ingredients and products? Are the test methods you need available? Will there be any method development required or is a compendia method applicable as is?
  4. How will you build your reference library? How much will it cost? What system can be put in place to monitor and track such samples?
  5. What will be the capacity or throughput of the department and does this match the turn-around time needed by your production schedules? What about overflow?

The time needed to get the program in place averages roughly 6-9 months until proficient enough to take off the training wheels. Logistical planning and delays due to insufficiently experienced or trained staff, complicated samples or adulterated materials can altogether halt routine production.

Let’s look at the approximate first year costs associated with setting up HP-TLC in house for Identity Testing to routinely test an average of 50 different botanicals / ingredients for routine testing or 5-10 samples/day. Keep in mind that this is one test method, and only for a small-scale plant ID program. Don’t forget metals, pesticides and micro biology which are required by prop 65. As you add others, the costs go up exponentially.

Lab Space Depends on a lot of variables and could be 5 or 7 figures.
Fume Hood ~$15,000
Lab furniture Depends on a lot of variables and could be 5 to 7 figures.
HPTLC Instrumentation ~$50,000-$60,000
Consumables (Reagents, Glassware, TLC Plates etc.) ~$15,000 -$20,000
Reference Standards (Chemical & Composite Reference Botanicals) ~$10,000 -$15,000
1 Full Time entry level Employee Salary + Benefits ~$45,000 – $65,000
A second one if you can’t afford down time ~$45,000 – $65,000
QA & Reporting ~$30,000
Total Budget Estimate  ~$195,000 – $210,000

                       
Subsequent years on-going Identity Testing In-house for 50 botanicals/ingredients for routine testing or 5-10 samples/day

Equipment Maintenance/Repairs  ~$12,000
Consumables (Reagents, Glassware, TLC Plates etc.)  ~$15,000-$20,000
Reference Standards ~$10,000 – $15,000
1 Full Time Employee Salary + Benefits ~$45,000 – $65,000
A second one if you can’t afford down time  ~$45,000 – $65,000
QA & Reporting ~$30,000
Total Budget Estimate after First Year ~$195,000

                                                          
So is it worth it? For some, yes, if management is prepared to make and support a significant investment in resources, as very few have proven to be thus far. For others, it may make sense to do a bit of in house testing and outsource the rest. For others, it makes more financial sense to completely outsource the testing, utilizing several labs with different areas of expertise. I always say do what you do best, and use outside sources for what you don’t do well. No matter what route is taken, one must be certain that the overall goal is the quality of the product and ultimately, the safety of the public. After all, isn’t that what the cGMP’s are all about?

A bright spot is a growing movement, let’s call it Next Generation Quality, which goes beyond the basic cGMP requirements and provides additional layers of transparency. How you source, manufacture, and test are all part of this commitment, including a relatively rare reveal: how and where your testing is performed. For the companies that have truly invested in quality, this is a great story to tell to gain and keep consumer trust and loyalty. It carries with it inherent vulnerability if corner cutting isn’t addressed, so for those aspiring to take quality and transparency to the next level, careful evaluation regarding in house labs is crucial.

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